Dennis Mellon
Arrangements Chair
American Society of Quality
arrangements@asq-silicon-valley.org
George Marcel
Program Chair
ASQ Silicon Valley - Section 0613
programs@asq-silicon-valley.org
Speaker Topic: Radiation Sterilization from Design to Production
Jeff Sauter will be presenting a case study in a local bay area start up that deals with extensive regulatory and processing requirements in providing radiation services to its customers, Jeff Sauter, Steri-Tek Director Business Development.
Steri-Tek is an ISO 11137 and ISO 13485 certified, FDA registered, DEA registered as well as State of California Medical Device and Drug Manufacturing licensed facility serving the medtech, biotech, pharmaceutical and other industries.
Jeff’s presentation will cover the processes and challenges in defining how Steri-Tek fulfills the best practice approach used, meeting industry standards, and properly supporting customer requirements from design services through validation as well as ongoing production. Discussion will cover critical design inputs and general controls including key control areas of:
1. Selection and optimization of the right source
2. Guiding Product Design
3. Best packaging configuration
Jeff Sauter
Director, Business Development
Steri-Tek
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Meeting agenda:
Registration has changed:
we are pleased to offer a discounted registration fee to registrants and guests if they 1) are members and 2) if they register at least one week before the event. It is $5 for full, senior, or fellow members and $15 for associate or student members. They will receive their (PayPal) rebate as soon as membership classification is verified - it will amount to dinner free.
For all other situations (register till Feb 19, non member) the usual registration fees apply. Registration is a three part process:1) having a meal? and 2) select meal if you are having one 3) pay for the meal via PayPal. Be sure to click the counter to the number of meals of each type (generally, 1)
Note: Advance registration ends at midnight Monday, February 19.
Member discounts end at midnight Monday, February 19
Cancellation Policy: no refunds will be available unless you notify us before Monday night(2/19) at midnight.
The ASQ Silicon Valley Leadership Team hopes to see you all at our dinner meeting!